Upstream Processing

The necessity to detach cells from a culture substrate during cell harvesting remains one of the most challenging steps in a cell-culture process.

Collaborative efforts are underway between suppliers and drug manufacturers to address raw material variability.

Microbial models offer some exciting production alternatives.

Miniature bioreactors add value by reducing validation efforts.

The authors review the status of expression of antibodies in microbial hosts and present the recent advances in the production of aglycosylated antibodies in bacteria.

Rapid methods to test CAR-T therapies for potential contamination are on the horizon.

The authors describe the impact of the knocking of the pgi gene of the wild type MG1655 strain on the growth kinetics of plasmid-free and plasmid-bearing cells.

In this article, the author reviews some of the techniques that can yield valuable information on protein stability, focusing specifically on protein aggregation. Emphasis is placed on the enhanced information made available when technologies are used orthogonally, and the alignment of different approaches with specific stages of the biopharmaceutical development workflow.

Novasep is building a new synthesis laboratory and adding capacity for kilogram-scale batches of synthetic molecules that are needed for biological testing and preclinical trials, at its Pennsylvania, US facility.

In semiconductor manufacturing, for example, a thorough understanding of process variation allows companies to manufacture circuits with billions of transistors at high yields. These variations are translated into a set of design rules, which help ensure that designs will be manufactured successfully and meet safety and other regulatory requirements.

The authors conclude that miniature bioreactors can adequately predict the cell culture kinetics in scaled-up reactors using equal mixing times.

Use of a subspace model is a viable method to characterize process space variables and optimize process performance.

Growing differentiated cells from stem cells may now be a bit easier than before, thanks to the findings from a new study on the production of liver cells. The study, backed by the Centre for Regenerative Medicine and published in Stem Cell Reports, finds that laminins may be a crucial element for the successful clinical-scale production and culture of stem cell therapies. The UK Regenerative Medicine Platform, the European Union Seventh Framework Programme, and the German Federal Ministry of Education and Research funded the research.

The authors present a review of the techniques commonly used for glycosylation analysis.

ProBioGen plans to develop and scale-up production of a biosimilar to the mAb cancer drug trastuzumab and will transfer the commercial manufacturing process to Indonesia’s government-owned Bio Farma.

Biovest’s mAbVault provides supply-chain redundancy for antibodies that enables customers to lock in price-per-gram protein production.

Probiodrug has signed an agreement with Rentschler Biotechnologie GmbH for the development of PBD-C06, a pGlu-Abeta-specific monoclonal antibody, as treatment for patients with Alzheimer’s disease.

Rafe Swan/Getty Images; Dan WardIrreproducible preclinical research is a global, expensive, and well-recognized problem that contributes to delays a

Aragen Bioscience has licensed ProteoNic Biotechnology’s 2G UNic recombinant protein production technology, which increases manufacturing efficiency and reduces cost of goods for recombinant biologicals.

Biopharmaceutical company BeiGene plans to build facility in Suzhou to expand its clinical capability and prepare for commercial manufacturing.

GEA's self-contained homogenizer is designed for laboratory applications, including cell dispersions.

A thorough cell-bank testing plan is necessary to certify the safety and purity of a resulting biopharmaceutical product.

The Mobius 2000-L single-use bioreactor from EMD Millipore offers configurable software, hardware, and single-use Flexware assemblies for suspension and adherent cell-culture applications.

Catalent licenses Excelimmune’s antibody combination therapy platform toenable the manufacture of multiple recombinant antibodies in a single batch culture.